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1 Precision Vascular Robotics Corindus Vascular Robotics (CVRS) March 2017

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Page 1: Precision Vascular Roboticss21.q4cdn.com/154318946/files/doc_presentations/2017… ·  · 2017-03-08LEGISLATION IN THE UNITED STATES AND ITS IMPACT ON HOSPITAL SPENDING, ... INCLUDING

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Precision Vascular Robotics

Corindus Vascular Robotics (CVRS)

March 2017

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Forward Looking Statements

THIS PRESENTATION CONTAINS “FORWARD-LOOKING STATEMENTS” (AS SUCH TERM IS DEFINED IN SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED), AND INFORMATION RELATING TO THE COMPANY, THAT ARE BASED ON THE CURRENT BELIEFS OF, AND ASSUMPTIONS MADE BY OUR MANAGEMENT AND THE INFORMATION CURRENTLY AVAILABLE TO OUR MANAGEMENT. FORWARD-LOOKING STATEMENTS RELATE TO EXPECTATIONS CONCERNING MATTERS THAT ARE NOT HISTORICAL FACTS. WORDS SUCH AS "ANTICIPATE," "BELIEVE," "ESTIMATE," "EXPECT," "INTEND," "PLAN," "PREDICT," "OPINION," "WILL" AND SIMILAR EXPRESSIONS AND THEIR VARIANTS, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. THESE FORWARD-LOOKING STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO STATEMENTS RELATED TO OUR EXPECTED BUSINESS, PRODUCTS, ADOPTION OF ROBOTIC MEDICAL PROCEDURES, RESULTS OF OPERATIONS, FUTURE FINANCIAL CONDITION, ABILITY TO INCREASE OUR REVENUES, AND SIMILAR MATTERS. THESE FORWARD-LOOKING STATEMENTS SHOULD BE CONSIDERED IN LIGHT OF VARIOUS IMPORTANT FACTORS, INCLUDING, WITHOUT LIMITATION, THE RATE OF ADOPTION OF OUR CORPATH SYSTEM AND THE RATE OF USE OF OUR CASSETTES; RISKS ASSOCIATED WITH MARKET ACCEPTANCE, INCLUDING PRICING AND REIMBURSEMENT; OUR ABILITY TO ENFORCE OUR INTELLECTUAL PROPERTY RIGHTS; OUR NEED FOR ADDITIONAL FUNDS TO SUPPORT OUR OPERATIONS; OUR ABILITY TO MANAGE EXPENSES AND CASH FLOW; FACTORS RELATING TO ENGINEERING, REGULATORY, MANUFACTURING, SALES AND CUSTOMER SERVICE CHALLENGES; POTENTIAL SAFETY AND REGULATORY ISSUES THAT COULD SLOW OR SUSPEND OUR SALES; THE EFFECT OF CREDIT, FINANCIAL AND ECONOMIC CONDITIONS ON CAPITAL SPENDING BY OUR POTENTIAL CUSTOMERS; THE IMPACT OF GLOBAL AND REGIONAL ECONOMIC AND CREDIT MARKET CONDITIONS ON HEALTH CARE SPENDING; HEALTH CARE REFORM LEGISLATION IN THE UNITED STATES AND ITS IMPACT ON HOSPITAL SPENDING, REIMBURSEMENT AND FEES WHICH WILL BE LEVIED ON CERTAIN MEDICAL DEVICE REVENUES, DECREASES IN HOSPITAL ADMISSIONS AND ACTIONS BY PAYERS TO LIMIT OR MANAGE SURGICAL PROCEDURES TIMING AND SUCCESS OF PRODUCT DEVELOPMENT AND MARKET ACCEPTANCE OF DEVELOPED PRODUCTS, PROCEDURE COUNTS; REGULATORY APPROVALS, CLEARANCES AND RESTRICTIONS; GUIDELINES AND RECOMMENDATIONS IN THE HEALTH CARE AND PATIENT COMMUNITIES, INTELLECTUAL PROPERTY POSITIONS AND LITIGATION, COMPETITION IN THE MEDICAL DEVICE INDUSTRY AND IN THE SPECIFIC MARKETS OF SURGERY IN WHICH WE OPERATE, THE INABILITY TO MEET DEMAND FOR PRODUCTS, THE RESULTS OF LEGAL PROCEEDINGS TO WHICH WE ARE OR MAY BECOME A PARTY, PRODUCT LIABILITY AND OTHER LITIGATION CLAIMS, ADVERSE PUBLICITY REGARDING OUR COMPANY AND SAFETY OF OUR PRODUCTS AND THE ADEQUACY OF TRAINING; OUR ABILITY TO EXPAND IN FOREIGN MARKETS; AND OTHER RISK FACTORS. READERS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH ARE BASED ON CURRENT EXPECTATION AND ARE SUBJECT TO RISKS, UNCERTAINTIES; AND ASSUMPTIONS THAT ARE DIFFICULT TO PREDICT, INCLUDING THOSE RISK FACTORS DESCRIBED IN THE COMPANY’S ANNUAL REPORT ON FORM 10-K FOR THE FISCAL YEAR ENDED ON DECEMBER 31, 2015. OUR ACTUAL RESULTS MAY DIFFER MATERIALLY AND ADVERSELY FROM THOSE EXPRESSED IN ANY FORWARD-LOOKING STATEMENTS. WE UNDERTAKE NO OBLIGATION TO PUBLICLY UPDATE OR RELEASE ANY REVISIONS TO THESE FORWARD-LOOKING STATEMENTS EXCEPT AS REQUIRED BY LAW.

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Robotics Market

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Robotics market expected to double in 4 years to $135B

Source: International Data Corporation

Auto-Driving Cars

Robotics in

Manufacturing

2015 2019

$135

$71

Robotics Market

(Billions) Robotics in Healthcare

Robots in

Hazardous Areas

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1 Market opportunity assessment based on market research reports and Corindus estimate 2 Peripheral Vascular includes lower limb, carotid, renal, iliac and AAA (abdominal aortic aneurysm) procedures 3 Millennium Research Group

Interventional Market Opportunity Large & growing worldwide market

• $4.5B FY2018 market estimate1

• Non-PCI procedure types: Peripheral

Vascular2, Neurointerventional and Structural

Heart

• 2018 estimated PCI procedure volume3:

− 933,000 in the US

− 1,800,000 OUS

• 2018 estimated non-PCI procedure volume3:

− 1,200,000 in the US

− 1,800,000 OUS $0.88B

PCI

$1.14B PCI

Market Opportunity

OUS

US

$4.5B1

$1.33B

NON-PCI

$1.19B

NON-PCI

5

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Corindus Today

A leader in vascular robotics

LARGE Market Opportunity with Long GROWTH Runway $4.5B1 market opportunity in 2018 driven by over 2.5 million coronary

and 3 million non-coronary procedures performed per year

DIFFERENTIATED Technology ONLY FDA cleared robotic platform for percutaneous coronary

intervention (“PCI”), radial PCI and peripheral interventions*

Proving BENEFIT to Physician, Patient, Hospital Studies have shown a greater than 95% reduction in radiation

exposure for the physician when using CorPath System2

Robust INTELLECTUAL PROPERTY Portfolio

With over 50 patents issued worldwide, Corindus has ring-fenced

patents around co-axial robotic movement

1 Market opportunity assessment based on market research reports and Corindus estimate 2 Weisz, G. et al. Safety and Feasibility of Robotic Percutaneous Coronary Intervention: PRECISE Study. J Am Coll Cardiol. 2013;61(15):1596-1600. PRECISE Trial was conducted with the CorPath 200 System.

*Only the CorPath 200 System is indicated for use in peripheral vascular interventions

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Recent Milestones

7

CAPITAL RAISE

$45 MILLION

Expected to close

March 15, 2017

New investors

included BSX,

BioStar Ventures,

Consonance

Capital, and Hudson

Executive Capital

Royal Philips and

HealthCor Partners

Management also

participated

STRATEGIC

AGREEMENT

Expansion to

Japan

Japan Medicalnext

became the

exclusive distributor

of Corindus products

in Japan*

Initial order for 12

CorPath GRX

Systems with $2

million advance

toward the purchase

price

GRX LAUNCH

1st Commercial

Cases

First procedures

using GRX System

Performed at

NewYork-

Presbyterian, UC

San Diego Health,

and University of

Virginia Health

System

Building Robotic

Programs

Multi-system orders

at Baylor Health and

the VA

MULTI-SYSTEM

ORDERS

*PMDA approval pending

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New Leadership & Strengthening Team

Building operational & clinical excellence

Mark Toland President & CEO

20 Year Medical

Device Veteran

J. Aaron Grantham, MD Chief Medical Officer Practicing Interventional

Cardiologist

Marty Leon, MD Executive Advisor

Interventional Cardiology

Thought Leader

Campbell Rogers, MD Board of Directors

CMO of Heartflow

8

Bill Lombardi, MD Steering Committee

University of Washington

David Kandzari, MD Steering Committee

Piedmont Heart

Sunil Rao, MD Steering Committee

Duke University

Ryan Madder, MD Steering Committee

Spectrum Health

Louis Cannon, MD Board of Directors

Managing Director, BioStar Ventures

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Struggle to see

angiography

Assess

Anatomy

Close proximity

ergonomic visualization

Trial & error, wire

spinning Navigate

Precise ‘Point & Shoot’

predictability

‘Eyeball’ estimate Measure

Anatomy

Robotic-assisted

sub-mm

Measurement

Manual adjustment Position

Stent

1mm precise

positioning

Devices loose during

inflation

Deploy

Stent

Fixated devices during

deployment

Manual

PCI

PCI

steps Robotic-assisted

PCI

Assess

Anatomy

Navigate

Measure

Anatomy

Position

Stent

Deploy

Stent

Traditional PCI vs CorPath Robotic PCI Robotic precision may improve outcomes, economics and safety

Today’s Cath Lab

Environment

• High radiation

exposure

• Significant fatigue

and orthopedic

strain

Robotic Cath Lab

• Shields from

radiation

• Potential to

reduce fatigue

and orthopedic

strain

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CorPath Clinical Benefit

10

Bedside improvements to enhance workflow

Open architecture

Potential to improve patient outcomes

Evidence of success in complex PCI

1mm movements for precise positioning

Sub mm measurement to select the most appropriate stent

Reduce stent utilization

Radiation protection to the physician

Potential to reduce long-term orthopedic issues

Smilowitz et al, “Robotic-Enhanced PCI Compared to the Traditional Manual Approach”, J Invasive Cardiol, 2014;26(7):318-321.

Campbell PT. et al. The Impact of Precise Robotic Lesion Length Measurement on Stent Length Selection: Ramification for stent savings. Cardiovasc Revasc Med. 2015;piii:S1553-8389.

Weisz, G. et al. Safety and Feasibility of Robotic Percutaneous Coronary Intervention: PRECISE Study. J Am Coll Cardiol. 2013;61(15):1596-1600. PRECISE Trial was conducted with the CorPath 200 System.

Clinical trials were conducted using the CorPath 200 System

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CorPath Technology Evolution

11

Generational improvements will fuel growth

45 Systems Placed

Demonstrated safety &

efficacy

Significant reduction in

physician radiation

exposure

Precise robotic movement

25-50% of cases could be

done with system

Increased speed and

efficiency*

More physician control*

Enhanced visualization for

improved accuracy*

Can perform more

complex cases*

Software enhancements

for Advanced Device

Manipulation planned

80-90% of cases can be

done with system

Remote Telestenting

capabilities to rural areas

globally

Auto Navigation of devices

for increased throughput

Digital data algorithms to

reduce variation of care

Machine learnings

BUILD

Enhance Physician’s

Skills

SCALE

Do Things Physician

Can’t Do Manually

GEN 1 GEN 2 GEN 3 LEARN

Protect Physician

* Compared to the CorPath 200 System

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The Next Generation is Here

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CorPath GRX System

* Compared to the CorPath 200 System

IMPROVED

WORKFLOW

FOR BEDSIDE

USER*

• Extended reach

arm

• Bedside

touchscreen for

step-by-step

instructions

INCREASED

PROCEDURAL

CONTROL FOR

PHYSICIAN*

• Active Guide

Catheter

Management

• 40’’ Power

Vision Monitor

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Building Robust Robotic Programs Driving strategic growth

13

Commercial Focus on Developing New Programs and Growing Adoption

Team

Approach

Commitment

to Building

a Program

Ongoing

Training

Adequate

Procedural

Volume

Physicians,

techs, nurses

and

administration

Buy in from all

stakeholders

Basic,

intermediate

and advanced

Support

multiple users

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Addressing Healthcare Challenges

Overdue paradigm shift into the digital age

14

Safer Work

Environment

Safer Work

Environment

Reduce Cost Expand Access

To Care

Improve

Efficiency Enhance

Quality

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Future of Cardiovascular Robotics

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The only platform for advanced capabilities

Expanded compatibility, precise actuation, multiple device control, quick exchange.

Advanced Device Manipulation

Algorithms to guide peri-procedure lesion assessment, treatment plan, and device selection.

Prescriptive Analytics

Automated wire techniques scaled to full auto-navigation of wires and catheters.

Robotic-Assisted Procedures

Tele-treatment capabilities spanning from remote case proctoring to remote catheterization.

Remote Capabilities

Planned features aimed at improving workflow, expanding access, and reducing variability of care.

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Technology Enablers

16

Third-party technologies that compliment robotics

Advanced

Imaging

3D Image Reconstruction

CT Fractional Flow Reserve (FFR)

Angiographic FFR

Data

Integration

Machine Learnings

Descriptive and Prescriptive Data

Algorithms

Autonomous

Sensors

Mapping

Closed Loop Movement

Communication

Advancement of 5G

Security Solutions

Latency Solutions

No Geographic Boundaries

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Telestenting First-in-Human Study

Study showed

86.4% technical

success and 95%

procedural

success

17

REMOTE-PCI

REMOTE-PCI Study explored feasibility

of remote telestenting using a robotic

system

Single-center

prospective

observational

study performed at

Spectrum Health,

Grand Rapids, MI

20 patients treated

via physician at

remote cockpit

leveraging telehealth

technology

Madder R, et al. “Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the

feasibility of telestenting (the REMOTE-PCI study).” Eurointervention, 2017;12:1569-1576. This study, conducted under local IRB, may involve off-label usage and was not sponsored by Corindus.

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Vascular Robotic Clinical Roadmap Demonstrating excellence in multiple lesion types and anatomies

Product Evolution

Ro

bo

tic s

yste

m c

ap

ab

ilit

y

Exploratory Feasibility Expand Use

NEURO

PERIPHERAL

PCI

18

STRUCTURAL

CorPath 200 and CorPath GRX Systems are indicated for PCI. Only the CorPath 200 System is indicated for use in peripheral vascular interventions.

CorPath Systems are not indicated for use in neuro or structural interventions.

• Below the Knee

• Ostial Stenting

• Atherectomy

• Drug Eluting Balloons

• Left Main Intervention

• Complex PCI & CTO

• Ostial Lesion

• Bioabsorbable Stents

• Staff Radiation

Protection

• Outcomes

• Remote PCI • Exploratory Work

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Corindus Vascular Robotics

Strategic Objectives

Near Term Mid to Long Term Mid to Long Term

Recurring revenue streams and

NG3 system launch

Expansion into additional

disease states (neurovascular

and structural heart)

Global expansion and remote

tele-proctoring, with specific

focus on China

Establish at least 25 new robotic

programs

Pursue co-development

opportunities, add at least one

additional collaboration

Drive system utilization

Prepare Japan distributor for

launch

Ramp up educational and training

opportunities for physicians

Further clinical trial development

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1 As of December 31, 2016 2 As of September 30, 2016 3 Outstanding principal balance 4 Per our press release filed on January 17, 2017

Financial Snapshot

Key Financial Metrics

Cash and Cash Equivalents1 $9.2 million

Debt2,3 $4.7 million

Basic Shares Outstanding2 119,025,221

Guidance

Year Robotic Programs Revenue

2017 Establish at least 25 new robotic programs $13 - $15 million4

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Corindus Vascular Robotics, Inc. is a global technology leader in robotic-

assisted vascular interventions. The company's CorPath® System is the first

FDA-cleared medical device to bring robotic-assisted precision to percutaneous

coronary interventions. With the CorPath System, Corindus Vascular Robotics

brings robotic precision to interventional procedures to help optimize clinical

outcomes and minimize the costs associated with complications of improper

stent placement with manual procedures.

Visit us at www.corindus.com

About Corindus Vascular Robotics

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